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Phase 3 Completed N=210 Prevention

Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)

Source: ClinicalTrials.gov NCT00964158 ↗
Enrolled (actual)
210
Serious AEs
0.5%
Results posted
Feb 2018
Primary outcomePrimary: Number of Subjects With Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value — 40 Participants
◆ Published Evidence
Established
34citations · ~2 / year
Immunogenicity and safety of AS03-adjuvanted H1N1 pandemic vaccines in children and adolescents.
Vaccine · 2011 · Likely link

Summary

This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years.

Linked Publications (2)

  • Immunogenicity and safety of AS03-adjuvanted H1N1 pandemic vaccines in children and adolescents.
    Vaccine · 2011 · 34 citations · Likely link
  • Safety and persistence of the humoral and cellular immune responses induced by 2 doses of an AS03-adjuvanted A(H1N1)pdm09 pandemic influenza vaccine administered to infants, children and adolescents: Two open, uncontrolled studies.
    Human vaccines & immunotherapeutics · 2015 · 9 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Subjects With Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value
40
PRIMARY
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
0; 6; 22; 41; 50; 87
PRIMARY
Titers for Serum HI Antibodies
5.0; 6.3; 8.9; 168.3; 284.4; 547.9
PRIMARY
Titers for Serum HI Antibodies
5.0; 6.3; 8.9; 168.3; 284.4; 547.9
PRIMARY
Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies
41; 50; 85; 41; 49; 80
PRIMARY
Number of Seroprotected (SPR) Subjects in Terms of HI Antibodies
194
PRIMARY
Seroconversion Factor (SCF) for HI Antibody Titers
33.7; 44.9; 61.8; 316.2; 151.7; 119.8
SECONDARY
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
0; 6; 22; 41; 50; 87
SECONDARY
Titers for Serum HI Antibodies
5.0; 6.3; 8.9; 168.3; 284.4; 547.9
SECONDARY
Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies
41; 50; 85; 41; 49; 80
SECONDARY
Number of Seroprotected Subjects in Terms of HI Antibodies
0; 3; 12; 41; 50; 87
SECONDARY
Seroconversion Factor (SCF) for HI Antibody Titers
33.7; 44.9; 61.8; 316.2; 151.7; 119.8
SECONDARY
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
25; 32; 28
SECONDARY
Titers for Serum Neutralizing Antibodies
269.1; 168.4; 118.1
SECONDARY
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
25; 32; 28
SECONDARY
Titers for Serum Neutralizing Antibodies
269.1; 168.4; 118.1
SECONDARY
Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies
24; 30; 25
SECONDARY
Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies
24; 30; 25
SECONDARY
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
40; 54; 91; 2; 3; 8
SECONDARY
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
9; 26; 0; 1; 8; 26
SECONDARY
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
9; 26; 0; 1; 8; 26
SECONDARY
Number of Subjects With Any Medically-attended Events (MAEs)
36; 21; 33
SECONDARY
Number of Subjects With Any Adverse Events of Specific Interest (AESIs), Including Potential Immune-mediated Disease (pIMDs)
0; 0; 0
SECONDARY
Number of Subjects With Normal or Abnormal Biochemical Levels
0; 0; 0; 0; 0; 0
SECONDARY
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
37; 26; 41; 8; 4; 7
SECONDARY
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
37; 26; 41; 8; 4; 7
SECONDARY
Number of Subjects With Serious Adverse Events (SAEs)
0; 0; 1

Eligibility Criteria

Inclusion Criteria

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
  • Children, male or female, aged between 3 and 17 years at the time of the first study vaccination.
  • Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable.
  • Healthy children as established by medical history and clinical examination when entering into the study.
  • Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user.

Exclusion Criteria

  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
  • Clinically or virologically confirmed influenza infection within six months preceding the study start.
  • Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
  • Acute disease and/or fever at the time of enrolment
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
  • Previous administration of any H1N1 A/California-like vaccine.
  • Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
  • If the subject is female and if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
  • Any known or suspected allergy to any constituent of influenza vaccines;a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
  • Known use of an analgesic or antipyretic medication within 12 hours prior to first vaccination.
  • Child in Care.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00964158) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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